Study of Stapokibart Injection in Subjects With Moderate... | NCT07210554

Studies
Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid

NCT07210554

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Status

Not yet recruiting

Last Update Posted

Oct 7, 2025Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Bullous Pemphigoid (BP)

Interventions

Stapokibart injection
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2025Estimated

Primary Completion Date

Mar 27, 2028Estimated

Completion Date

May 8, 2028Estimated

First Submitted Date

Sep 30, 2025

First Submission Date that Met QC Criteria

Sep 30, 2025

First Posted Date

Oct 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2025

Last Update Posted Date

Oct 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Stapokibart in subjects with Moderate to Severe Bullous Pemphigoid.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental		Biological: Stapokibart injection
Group 2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stapokibart injection	Biological	subcutaneous injection	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of subjects achieving sustained complete remission (CR) at W36	Sustained complete remission (CR) defined as discontinuation of oral corticosteroid (OCS) therapy and achievement of CR on or before Week 16, no relapse during the period from OCS discontinuation up to Week 36, and no requirement for rescue therapy up to Week 36.	Up to 36 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to understand the study content and voluntarily sign the Informed Consent Form (ICF).
Aged between 18 and 90 years, inclusive, regardless of gender.
Confirmed diagnosis of bullous pemphigoid prior to randomization.
Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥ 24 points at the screening visit and at randomization.
Weekly average of the Pruritus Numerical Rating Scale (NRS) score ≥ 4 points at randomization.
Karnofsky Performance Status score ≥50% at the screening visit.

Exclusion Criteria:

Diagnosis of other forms of pemphigoid or other autoimmune blistering diseases.
Presence of other active skin comorbidities that may interfere with the study evaluations, apart from bullous pemphigoid.
Insufficient washout period for prior treatments.
Any condition that, in the opinion of the investigator, would preclude the subject's participation in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qian Jia	Contact	86+028-88610620		qianjia@keymedbio.com

Overall Officials

Name	Affiliation	Role
Hang Li, Chief physician	Peking University First Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing	Beijing Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D010391	Pemphigoid, Bullous

Ancestor Terms

ID	Term
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases

Browse Leaves

Not provided

Browse Branches

Not provided